Cleared Traditional

K992404 - THE WAND

K992404 is an FDA 510(k) clearance for THE WAND, manufactured by Spintech, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K992404 · Spintech, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
323d
Days
Class 2
Risk

K992404 is an FDA 510(k) clearance for the THE WAND. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Spintech, Inc. (Washington, US). The FDA issued a Cleared decision on June 6, 2000 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Spintech, Inc. devices

FDA 510(k) Submission Details - K992404

510(k) Number K992404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1999
Decision Date June 06, 2000
Days to Decision 323 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 129d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 330
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K992404.
DUPLOGRIP
K003193 · Baxter Healthcare Corp · Nov 2000
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
TERUMO U-100 INSULIN SYRING
K001474 · Terumo Medical Corp. · Jun 2000
NIPRO INSULIN SYRINGE
K000144 · Nipro Medical Corp. · Feb 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
TERUMO U-100 INSULIN SYRINGE
K992802 · Terumo Medical Corp. · Sep 1999